The efficacy and safety of difelikefalin for pruritus in hemodialysis patients: a systematic review and meta-analysis of randomized controlled trials.

IF 3 3区 医学 Q1 UROLOGY & NEPHROLOGY
Renal Failure Pub Date : 2024-12-01 Epub Date: 2024-08-01 DOI:10.1080/0886022X.2024.2384590
Abdallah Saeed, Iman Abdelhady Elshnoudy, Yehya Khlidj, Radwa Radwan, Mariam Kamal, Mahmoud Hamdi, Abdullah Alsaid, Mustafa Turkmani, Mohamed Abuelazm
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引用次数: 0

Abstract

Background: Chronic kidney disease-associated pruritus (CKD-ap) is a common complication that negatively affects the quality of life. Difelikefalin has emerged as a novel FDA-approved drug to manage CKD-ap. This systematic review and meta-analysis will assess the efficacy and safety of Difelikefalin versus placebo to manage CKD-ap.

Methods: PubMed, Scopus, WOS, Central, and Embase were systematically searched until November 2023. RevMan was used to perform meta-analysis. Quality assessment was conducted using the Cochrane RoB 2.0 tool. Results were reported as risk ratio (RR) and mean difference (MD) with a 95% confidence interval (CI). PROSPERO ID: (CRD42023485979).

Results: Five RCTs with a total of 896 participants were included. Difelikefalin significantly decreased the weekly mean WI-NRS score (MD: -0.99 [-1.22, -0.75], p ˂ .00001), 5-D itch scale total score (MD: -1.51 [-2.26, -0.76], p > .0001), and Skindex-10 total score (MD: -7.39 [-12.51, -2.28], p = .005), but showed significantly higher adverse events (RR: 1.26 [1.03, 1.55], p = .03), versus placebo. However, there was no significant difference between both groups in serious adverse events (RR: 1.42 [0.78, 2.57], p = .25) or death (RR: 0.81 [0.19, 3.34], p = .77).

Conclusion: Difelikefalin appears to be a promising agent for the management of CKD-induced pruritus in patients with end-stage renal disease. However, evidence is still underpowered due to the paucity of the current data; therefore, more robust RCTs are required to confirm the benefit of Difelikefalin.

地匹福林治疗血液透析患者瘙痒症的有效性和安全性:随机对照试验的系统回顾和荟萃分析。
背景:慢性肾病相关性瘙痒症(CKD-ap)是一种常见的并发症,对患者的生活质量造成了负面影响。美国食品及药物管理局(FDA)批准了一种新型药物用于治疗慢性肾脏病相关性瘙痒症。本系统综述和荟萃分析将评估地夫利卡林与安慰剂相比在控制 CKD-ap 方面的疗效和安全性:方法:系统检索了 PubMed、Scopus、WOS、Central 和 Embase,直至 2023 年 11 月。使用RevMan进行荟萃分析。使用 Cochrane RoB 2.0 工具进行质量评估。结果以风险比 (RR) 和平均差 (MD) 以及 95% 置信区间 (CI) 的形式报告。PROSPERO ID:(CRD42023485979):结果:共纳入了五项 RCT,共有 896 名参与者。Difelikefalin可显著降低每周平均WI-NRS评分(MD:-0.99 [-1.22, -0.75],p ˂ .00001)、5-D痒量表总分(MD:-1.51 [-2.26, -0.76],p > .0001)和 Skindex-10 总分(MD:-7.39 [-12.51,-2.28],p = .005),但与安慰剂相比,不良事件(RR:1.26 [1.03,1.55],p = .03)显著增加。然而,两组在严重不良事件(RR:1.42 [0.78,2.57],p = .25)或死亡(RR:0.81 [0.19,3.34],p = .77)方面没有明显差异:结论:对于治疗终末期肾病患者由 CKD 引起的瘙痒症,地夫瑞克法林似乎是一种很有前景的药物。然而,由于目前的数据较少,证据仍不够充分;因此,需要更多可靠的 RCT 来证实 Difelikefalin 的益处。
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来源期刊
Renal Failure
Renal Failure 医学-泌尿学与肾脏学
CiteScore
3.90
自引率
13.30%
发文量
374
审稿时长
1 months
期刊介绍: Renal Failure primarily concentrates on acute renal injury and its consequence, but also addresses advances in the fields of chronic renal failure, hypertension, and renal transplantation. Bringing together both clinical and experimental aspects of renal failure, this publication presents timely, practical information on pathology and pathophysiology of acute renal failure; nephrotoxicity of drugs and other substances; prevention, treatment, and therapy of renal failure; renal failure in association with transplantation, hypertension, and diabetes mellitus.
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